MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

Catalog Number B-2240

Device Problem Device Slipped (1584)

Patient Problem Prolapse (2475)

Event Date 11/17/2010

Event Type  Injury  

Event Description

Health professional reported "gastric prolapse/band slippage: treated with deflation and lap-band ap system removal.".

Manufacturer Narrative

The reporter of the complaint was asked to return the product for analysis.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Based upon the model number, serial number and implant date provided by the reporter,the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Band slippage and pouch dilation are surgical/physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported events of band slippage and pouch dilation as follows: "band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band"."frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation".

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117-5506 ; 8059615867
• MDR Report Key: 4012835
• MDR Text Key: 4781419
• Report Number: 2024601-2014-00393
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2011
• Device Catalogue Number: B-2240
• Device Lot Number: 1786238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR